FDA Greenlights First Robotic PCI System

The FDA has approved the first robotic-assisted percutaneous coronary intervention (PCI) system, the CorPath 200, according to manufacturer Corindus Vascular Robotics.

The 510(k) clearance by the FDA comes on the strength of the PRECISE trial, a prospective, single-arm, multicenter study whose results were presented in May at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Of the 162 procedures performed with the robotic technology in PRECISE, only two cases had to be converted to manual stent implantation -- and the fault was not that of the robotic system, Giora Weisz, MD, of Columbia University Medical Center in New York City, reported at the time.

However, widespread adoption of the technology could be hampered by the fact that there is no incremental reimbursement for using the robotic system, Joseph P. Carrozza Jr., MD, chief of cardiovascular medicine at St. Elizabeth's Medical Center in Boston and a principal investigator for PRECISE, told MedPage Today.

But Carrozza said he is ready to present the case to his administration for the purchase of the technology, a sentiment shared by all the operators in PRECISE. "And that's unusual for interventional cardiologists because we don't agree on many things," he said.

One of the advantages of the robotic assistance is that the interventional cardiologist sits at a console away from the fluoroscopy system, thereby reducing operator radiation exposure. Consequently, they do not need to wear lead aprons, which reduces the amount of fatigue one feels at the end of the day, Carrozza said.

He said the technology also enables more precise placement of stents, can help decrease procedure time, and potentially reduces the amount of contrast media used, although the PRECISE trial was not designed to measure these outcomes.

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